Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095589
• Other study ID #: J0382
• Secondary ID: U01CA084968P30CA
• Status: Completed
• Start date: August 2004
• Est. completion date: June 2009

Study information

• Verified date: February 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures.

PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

Description:

OBJECTIVES:

Primary

• Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine sediment with cystoscopy and urine cytology for detecting bladder cancer in participants undergoing cystoscopy.

Secondary

• Determine the temporal performance characteristics of MSA in urine sediment from these participants.

• Determine which of the 15 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer in these participants.

OUTLINE: This is a single-blind, multicenter, cohort study.

Urine and blood specimens are collected from all participants at baseline. Urine specimens are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in groups 2 and 3 also undergo cystoscopy at baseline.

Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan), microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the absence of progressive disease.

Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476, D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.

PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for group 3) will be accrued for this study.

Other known NCT identifiers

• NCT00185627

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Group 1 (healthy volunteers):

• No prior or concurrent urologic disease or devices

• No genitourinary (GU) complaints, including urgency or frequency of urination

• Normal urinalysis and urine cytology

• Never smoked cigarettes regularly (i.e., = 1 cigarette/day for = 1 year)

• No suspected exposure to environmental bladder carcinogens for > 1 year, including, but not limited to, the following occupations or exposures:

• Aluminum industry

• Aromatic amines

• Coal gasification

• Coal tars and pitches

• Coke plant

• Dye industry

• Leather industry

• Machinist

• Painter

• Rubber industry

• Truck, bus, or taxi drivers

• Group 2 (participants with condition(s) that lead to false-positive urinary bladder cancer screening studies):

• GU complaints requiring cystoscopy

• No current GU malignancy

• At least 1 of the following conditions:

• Benign prostatic hypertrophy (International Prostate Symptom Score > 12)

• Foreign bodies (stones, stents, or catheters)

• Hematuria (gross or microscopic)

• GU infection (e.g., prostatitis, urinary tract infection, pyelonephritis, urethritis) within the past 3 months and completed treatment

• No sign of infection at the time of study participation

• Group 3 (superficial bladder cancer patients):

• Histologically confirmed superficial bladder urothelial malignancy

• Primary or recurrent disease

• No nontransitional cell carcinoma of the bladder, upper tract tumors, muscle-invasive tumors, or superficial disease for which local therapy is not appropriate

PATIENT CHARACTERISTICS:

Age

• Over 40

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• See Disease Characteristics

Other

• No prior cancer except nonmelanoma dermatologic malignancy

• Prior bladder cancer allowed for group 3 patients

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

• Prior intravesical therapy for bladder cancer allowed for group 3 patients

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Genetic:
• loss of heterozygosity analysis

• microarray analysis

• microsatellite instability analysis

Other:
• cytology specimen collection procedure

• laboratory biomarker analysis

Procedure:
• computed tomography

• cystoscopy

Locations

Country	Name	City	State
Canada	Edmond Odette Cancer Centre at Sunnybrook	Toronto	Ontario
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	Houston	Texas
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Grand Strand Urology, LLP	Myrtle Beach	South Carolina
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Stanford Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,